Compressible connector for an inner cannula

ABSTRACT

A tracheal tube assembly includes an outer cannula configured to be positioned in a patient airway and an inner cannula configured to be disposed inside the outer cannula. The tracheal tube assembly further includes a flange member secured about the outer cannula, and an outer cannula connector coupled to a proximal end of the outer cannula. The inner cannula includes a compressible proximal end region that is compressed while secured inside the outer cannula connector.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of prior U.S. application Ser. No.14/683,515, filed Apr. 10, 2015, which is a continuation of prior U.S.application Ser. No. 13/565,273, filed Aug. 2, 2012 (patented as U.S.Pat. No. 9,010,326), the specification of which is incorporated hereinby reference in its entirety for all purposes.

BACKGROUND

The present disclosure relates generally to the field of tracheal tubesand, more particularly, to a tracheal tube including an inner cannulawith a compressible end.

This section is intended to introduce the reader to various aspects ofart that may be related to various aspects of the present disclosure,which are described and/or claimed below. This discussion is believed tobe helpful in providing the reader with background information tofacilitate a better understanding of the various aspects of the presentdisclosure. Accordingly, it should be understood that these statementsare to be read in this light, and not as admissions of prior art.

A wide variety of situations exist in which artificial ventilation of apatient may be desired. For short-term ventilation or during certainsurgical procedures, endotracheal tubes may be inserted through themouth to provide oxygen and other gasses to a patient. For otherapplications, particularly when longer-term intubation is anticipated,tracheostomy tubes may be preferred. Tracheostomy tubes are typicallyinserted through an incision made in the neck of the patient and throughthe trachea. A resulting stoma is formed between the tracheal ringsbelow the vocal chords. The tracheostomy tube is then inserted throughthe opening. In general, two procedures are common for insertion oftracheostomy tubes, including a surgical procedure and a percutaneoustechnique.

Such tubes may include an inner cannula, such as a reusable innercannula, or a disposable inner cannula. The inner cannula may bedisposed inside the tracheostomy tube and used as a conduit for liquidsor gas incoming and outgoing into the patient's lungs. The inner cannulamay be removed for cleaning and for disposal of secretions withoutdisturbing the placement of the tracheostomy tube. A connector istypically provided at an upper or proximal end where the tube exits thepatient airway, suitable for coupling the ventilator with the innercannula. In one embodiment, the inner cannula may be removed, cleaned,and reused. In another embodiment, the inner cannula may be disposable,and a new inner cannula may then be positioned inside of the trachealtube. By enabling the cleaning and/or replacement of the inner cannula,a ventilation circuit may be kept clean and free of secretions.

Standard connectors have been developed to allow the tracheal tube tothen be fluidly coupled to artificial ventilation equipment to supplythe desired air or gas mixture to the patient, and to evacuate gasesfrom the lungs. One difficulty that arises in the use of tracheal tubes,and tracheostomy tubes in particular, is in the connection of the tubeto the ventilation equipment. For example, an inner cannula may not beinstalled, or may be installed improperly. This may lead to difficultieswith ventilation when a connection is made to ventilation equipment.

There is a need, therefore, for improved tracheal tubes, andparticularly for improved tracheostomy tubes. It would be desirable toprovide a tube that allows for ease of placement and connection of theinner cannula during ventilation.

BRIEF DESCRIPTION

This disclosure provides a novel tracheal tube designed to respond tosuch needs with a low insertion force and a high retention force. Thetracheal tube may be a tube with a separate inner cannula and outercannula. The inner cannula includes a compressible end, such as a pinchend, that allows for ease of insertion into the outer cannula. Incontrast to other types of inner cannula connectors, such as threaded orsnap-on connectors, the disclosed embodiments may provide inner cannulasthat may be inserted and connected in a single movement and that alsoresist axial or rotational displacement relative to the outer cannula.In particular embodiments, the entire proximal end of the inner cannula,including any cap or lip portion, is smaller in diameter than the widestportion of the outer cannula connector when properly inserted. In thismanner, the outer cannula connector forms the connector portion (e.g., astandard 15 mm connector) for attachment to upstream medical tubingand/or devices. This is in contrast to disposable inner cannulas that,when inserted into an outer cannula and connector, have integral 15 mmconnectors. Accordingly, in the disclosed embodiments, the standardconnector resides on the outer cannula portion of the tracheal tube,which may allow the outer cannula assembly to be connected to upstreammedical tubing with or without an inserted inner cannula.

Further, the compressible end of the inner cannula may be adhered to orotherwise affixed to the inner cannula to form its proximal end regionor may be manufactured as a unitary assembly, such as a single moldedpiece, which may be a cost-effective manufacturing technique. Thedisclosed tracheal tubes provide improved inner/outer cannula connectionwhile also maintaining standard connections to other medical tubing,such as ventilator tubing.

Thus, in accordance with a first aspect, a tracheal tube assemblyincludes an outer cannula configured to be positioned in a patientairway. The assembly further includes a flange member secured about theouter cannula and an outer cannula connector coupled to a proximal endof the outer cannula. The assembly further includes an inner cannulaconfigured to be disposed inside the outer cannula such that the innercannula and the outer cannula are coaxial. The inner cannula features acompressible proximal region that is configured to be positioned insidethe outer cannula connector. The compressible proximal region is capableof assuming a compressed configuration and an uncompressedconfiguration. The compressed configuration is assumed when thecompressible proximal end region is positioned in the outer cannulaconnector, and the uncompressed configuration is assumed when thecompressible proximal end region is not subjected to any biasing forces.

In accordance with another aspect, a tracheal tube inner cannulaincludes a conduit configured to be inserted into an outer cannula totransfer gas to a patient, the conduit comprising a flared proximalregion, wherein the flared proximal region is configured to be insertedin an outer cannula connector. The flared proximal region includes afirst ear and a second ear separated by opposing notches formed in awall of the flared proximal region, wherein the opposing notches extendfrom the flared proximal region towards a distal end of the innercannula such that an outer circumference of a proximal end of the innercannula is a broken annulus and wherein the first ear and the second earare configured to be biased towards one another when the flared proximalregion is inserted in the outer cannula connector.

Also disclosed herein is a tracheal tube assembly kit that includes anouter cannula configured to be positioned in a patient airway; a flangemember secured about the outer cannula; an outer cannula connectorcoupled to a proximal end of the outer cannula; and an inner cannulaconfigured to be disposed inside the outer cannula comprising: a conduitconfigured to be inserted into an outer cannula to transfer gas to apatient, the conduit comprising a flared proximal region, wherein theflared proximal region is configured to be inserted in an outer cannulaconnector and wherein the flared proximal region comprises a first earand a second ear separated by opposing gaps formed in a wall of theflared proximal region, wherein the first ear and the second ear areconfigured to be biased towards one another when the flared proximalregion is inserted in the outer cannula connector.

Also disclosed herein is a tracheal tube inner cannula mold. The moldincludes a mold form defining a conduit, wherein the conduit comprises:a distal end; a flared proximal region comprising a first ear and asecond ear separated by opposing notches formed in a wall of the flaredproximal region, wherein the opposing notches extend from the flaredproximal region towards a distal end of the inner cannula such that anouter circumference of a proximal end of the inner cannula is a brokenannulus; a first protrusion formed on an outer surface of the first earand a second protrusion formed on an outer surface of the second ear,wherein the opposing notches extend distally past the first protrusionand the second protrusion.

BRIEF DESCRIPTION OF THE DRAWINGS

Various aspects of the disclosed techniques may become apparent uponreading the following detailed description and upon reference to thedrawings in which:

FIG. 1 is a perspective view of a tracheal tube with a compressibleinner cannula connector inserted into a patient in accordance withembodiments of the present disclosure;

FIG. 2 is a perspective view of the tracheal tube of FIG. 1;

FIG. 3 is a perspective view of a separate inner cannula and outercannula assembly of the tracheal tube of FIG. 1;

FIG. 4 is a partial perspective view of a tracheal tube with the innercannula inserted in the outer cannula connector;

FIG. 5 is perspective view of an inner cannula with a compressibleconnector in accordance with embodiments of the present disclosure;

FIG. 6 is a partial perspective view of the compressible connectorregion of the inner cannula of FIG. 5;

FIG. 7 is a top view of the compressible connector region of the innercannula of FIG. 5

FIG. 8 is a partial perspective view of an inner cannula inserted intothe outer cannula connector component;

FIG. 9 is a perspective view of an outer cannula connector component;

FIG. 10 is a cross-sectional view of the outer cannula connectorcomponent of FIG. 9; and

FIG. 11 is a perspective view of a tracheal tube assembly including aninner cannula with a compressible connector used in conjunction with anobturator.

DETAILED DESCRIPTION OF SPECIFIC EMBODIMENTS

One or more specific embodiments of the present techniques will bedescribed below. In an effort to provide a concise description of theseembodiments, not all features of an actual implementation are describedin the specification. It should be appreciated that in the developmentof any such actual implementation, as in any engineering or designproject, numerous implementation-specific decisions must be made toachieve the developers' specific goals, such as compliance withsystem-related and business-related constraints, which may vary from oneimplementation to another. Moreover, it should be appreciated that sucha development effort might be complex and time consuming, but wouldnevertheless be a routine undertaking of design, fabrication, andmanufacture for those of ordinary skill having the benefit of thisdisclosure.

The tracheal tubes as provided herein are disposable rather thanreusable, capable of providing differential mechanical ventilation toeither or both lungs, and capable of supporting all other functions ofstandard tracheal tubes (e.g. sealing, positive pressure generation,suctioning, irrigation, drug instillation, etc). The tracheal tubes canbe used in conjunction with all acceptable auxiliary airway devices suchas (e.g. heat and humidity conservers, mechanical ventilators,humidifiers, closed suction systems, scavengers, capnometers, oxygenanalyzers, mass spectrometers, PEEP/CPAP devices, etc). Furthermore,although the embodiments of the present disclosure illustrated anddescribed herein are discussed in the context of tracheal tubes such astracheostomy tubes, it should be noted that presently contemplatedembodiments may include a tracheal tube assembly including an innercannula with a compressible end used in conjunction with other types ofairway devices. For example, the disclosed embodiments may be used inconjunction with a single-lumen tube, an endotracheal tube, adouble-lumen tube (e.g., a Broncho-Cath™ tube), a specialty tube, or anyother airway device with a main ventilation lumen. Indeed, any devicewith a ventilation lumen designed for use in an airway of a patient mayinclude an inner cannula with a compressible end as provided. As usedherein, the term “tracheal tube” may include an endotracheal tube, atracheostomy tube, a double-lumen tube, a bronchoblocking tube, aspecialty tube, or any other airway device.

Turning now to the drawings, FIG. 1 is a perspective view of anexemplary tracheal tube 10 placed in a patient's airway in accordancewith aspects of the present disclosure. The tracheal tube assembly 10represented in the figures is a tracheostomy tube, although aspects ofthis disclosure could be applied to other tracheal tube structures, suchas endotracheal tubes. The application to a tracheostomy tube is apt,however, insomuch as such tubes tend to be worn for longer periods oftime and, thus, may include a removable and/or disposable inner cannuladisposed inside of an outer cannula 12, which is useful in maintaining aclean ventilation circuit.

The tracheal tube 10 includes an outer cannula 12 that defines aventilation lumen and that facilitates the transfer of gases to and fromthe lungs. The tracheal tube 10 includes an inflatable cuff 16 disposedon the outer cannula 12. However, certain embodiments of the disclosuremay be used in conjunction with cuffless tubes. A proximal end of thetracheal tube 10 may connect to upstream airway devices (e.g., aventilator) via the appropriate medical tubing and/or connectors. Inembodiments that include a cuff 16, a pilot balloon and inflation lineassembly 18 is coupled to the cuff 16.

The outer cannula 12 is illustrated extending both distally as well asproximally from a flange member 20. A pair of side wings of the flange20 extend laterally and serve to allow a strap or retaining member (notshown) to hold the tube assembly 10 in place on the patient. In oneembodiment, apertures formed in each side of the flange member 20 allowthe passage of such a retaining device. In many applications, the flangemember 20 may be taped or sutured in place as well. During intubation,the tracheal tube assembly 10 is placed through an opening formed in theneck and trachea of a patient and extending into the patient airway. Incertain embodiments, the tracheal tube assembly 10 is curved toaccommodate the curved tracheal passageway. For example, the outercannula 12 may be curved in an unbiased state (i.e., outside thepatient) such that an inner curve 22 is generally positioned on aventral side of the patient while the outer curve 24 is positioned onthe dorsal side of the patient when the tracheal tube assembly 10 isinserted in the patient. Further, while a distal portion of the outercannula 12 is inserted within the patient, a proximal portion of theouter cannula 12 forms an outer cannula connector 28. As providedherein, the outer cannula connector 28 receives a compressible endregion of the inner cannula and forms a secure connection.

FIG. 2 is a perspective view of the tracheal tube assembly 10 showing aninner cannula 30 inserted in the outer cannula 12 and forming aconnection with the outer cannula connector 28. The compressible endregion 32 is disposed within the outer cannula connector 28 such that aproximal end 34 is exposed (i.e., is not within the outer cannulaconnector 28). The inner cannula 30 is generally coaxial with the outercannula 12 and is shaped to fit within the outer cannula 12 to form thegas conveying passageway to the patient. In this manner, the innercannula 30 may be removed and replaced while the outer cannula 12 isretained. This reduces stress on the stoma while permitting cleaning ofthe passageway.

The inner cannula 30 may be manually inserted into the outer cannula 12.As shown in FIG. 3, the inner cannula 30 may be inserted by pushing thedistal end 40 through the proximal end 44 of the outer cannula 12, e.g.,in the direction of arrow 46. The insertion is complete when the distalend 40 is generally located at or near the distal end 48 of the outercannula 12. In certain embodiments, the distal end 40 of the innercannula 30 terminates short of the distal end 48 of the outer cannulaand is disposed entirely within the outer cannula. When the innercannula 30 is inserted, the compressible end region 32 is disposed atleast in part within the outer cannula connector 28. In embodiments inwhich the outer cannula forms a curve, such as a Magill curve, the innercannula 30 may also be curved in a complementary fashion. Accordingly,the insertion may be directional such that proper insertion involves aninner curve 50 of the inner cannula 30 located proximate to orcorresponding with the inner curve 22 of the outer cannula 12.Similarly, the outer curve 52 of the inner cannula 30 will be locatedproximate to the outer curve 24 of the outer cannula 12. The positioningof the inner cannula 30 in the outer cannula 12 may be facilitated byoperator technique and, in particular embodiments, with the aid ofmarkings, instructions, or other visual indicators.

The inner cannula 30 forms a conduit from which liquids or gases,including medications, may enter through the proximal end 34. Both theinner cannula 30 and the outer cannula 12 have dimensions selected tofit easily through the stoma. In practice, a range of such tubes may beprovided to accommodate the different contours and sizes of patients andpatient airways. Such tube families may include tubes designed forneonatal and pediatric patients as well as for adults. By way of exampleonly, the outer cannula 12 of the tube 10 may range from 4 mm to 16 mm.The inner cannula 30 may be sized to correspond with an appropriateouter cannula 12. The outer cannula 12 and the inner cannula 30 may becharacterized by their inner diameters (referring to the diameter of theinterior of the passageway) or their outer diameters (referring to thediameter as measured from the exterior outside wall to exterior outsidewall).

Because the inner cannula 30 fits within the outer cannula 12, the outercannula 12 features a larger inner diameter 60 relative to an outerdiameter 64 of the inserted portion 54 of the inner cannula 30. Theouter diameter 64 of the inner cannula 30 may be selected to allowsufficient air flow while also fitting comfortably within the outercannula 12 and allowing for appropriate insertion force. The innerdiameter of the outer cannula 12 is less than the outer diameter 64 bythe thickness of the walls of the inner cannula 30. For example, aninner cannula 30 sized to 6.5 mm may have an outer diameter 64 of about6.5 mm and an inner diameter of about 5.5 mm. In such an embodiment, theinner cannula walls are about 1 mm thick in the inserted portion of theinner cannula 30 (e.g., in portions distal of the compressible endregion 32). Similarly, a 10 mm inner cannula 30 may have an innerdiameter of about 9 mm. Accordingly, tubes sized to 6.5 mm, 7.0 mm, 7.5mm, 8.0 mm, 8.5 mm, 9.0 mm, or 10 mm may feature smaller inner diametersthat define the airflow passage.

Further, the inner diameter 62 at the proximal end 44 of the outercannula 12 is typically larger than the inner diameter 60 and isselected to couple to appropriate tubing. That is, the outer cannula 12is narrower in the inserted portion and is wider at the connector. Thecompressible end region 32 also has a larger outer diameter 70 relativeto the inserted portion 54. In certain embodiments, the compressible endregion may flare or taper outwards gradually such that the diameterincreases gradually, with the largest diameter 70 at the proximal end34. In other embodiment, the compressible end region 32 may include agenerally barrel-shaped region with an outer diameter 70. It should beunderstood that the compressible end region 32 may change undercompression. Accordingly, the outer diameter 70 refers to theuncompressed configuration. Further, in embodiments in which theproximal end 34 forms a broken annulus (i.e., is not a continuouselement), the outer diameter 70 refers to a diameter between the solidportions of the proximal end 34. When the compressible end region 32 iswithin the outer cannula connector 28, the outer cannula connector 28provides a biasing force that compresses the compressible end region 32into a compressed configuration that is sized to fit within the innerdiameter 62 of the outer cannula connector 28. The outer diameter 70 islarger than a largest outer diameter of the inner cannula 30 in thecompressed configuration.

The compressed configuration of the inner cannula 30 is shown in FIG. 4,which is a partial perspective view of the proximal region 80 of thetracheal tube assembly 10. In the compressed configuration, thecompressible end region 32 is constrained by the wall 82 of the outercannula connector 28. Accordingly, the outer diameter 84 is smaller thanthe outer diameter 70 (see FIG. 3) of the uncompressed configuration. Inone embodiment, the outer diameter 84 is about 15 mm or slightlysmaller. That is, uncompressed outer diameter 70 is about the outerdiameter of a 15 mm connector. The resulting proximal opening 86 of theinner cannula 30 is also smaller. In a specific embodiment, the materialof the compressible end region 32 is selected so that an operator iscapable of changing the configuration of the compressible end region 32through the application of a biasing force. Similarly, the wall 82 ofthe outer cannula connector 28 is sufficiently strong to maintain thecompressible end region 32 in the compressed configuration. In anotherembodiment, the compressible end region 32 includes one or more notchesor openings 90 that facilitate the change from the uncompressedconfiguration to the compressed configuration. In the compressedconfiguration, the gap 92 formed by the opening 90 is smaller than inthe uncompressed configuration.

The opening 90 allows the proximal end 34 of the inner cannula 30 toform a smaller compressed diameter 84 under a compression force withoutwrinkling and while maintaining a generally circular cross-section overthe inserted portion of the compressible end region 32 that correspondswith the generally circular cross-section of the outer cannula connector28. The size and number of openings 90 may be selected according to thesize and manufacturing of the inner cannula 30. In one embodiment, thecompressible end region has two openings 90. In embodiments with onlyone opening 90, the size of the gap 92 in the uncompressed configurationmay be relatively larger to facilitate the change from uncompressed tocompressed with fewer openings. In another embodiment, if more openings90 are used, the corresponding gaps 92 may be smaller. That is, incertain embodiments, the total space accounted for in the gaps 92 isabout the same regardless of the number of openings. The size of thegaps 92 may be measured in either the compressed or the uncompressedconfiguration, and may be a largest space between the adjacent portionsof the inner cannula wall 94.

The outer cannula connector 28 may be formed in accordance with industrystandards to permit and facilitate connection to ventilating equipment(not shown). By way of example, the outer cannula connector 28 is a 15mm connector, although other sizes and connector styles may be used.Additionally, the tracheal tube assembly 10 may be connected to othermedical devices, such as a suction device, a T-junction, a medicinedelivery system, and so forth. Indeed, the outer cannula connector 28may enable the attachment of one or more medical devices to the trachealtube assembly 10. To accommodate such a connection, the compressible endregion 32 may be formed such that, when inserted, the inner cannula 30does not interfere with coupling via the outer cannula connector 28. Tothat end, in particular embodiments, the widest diameter 84 of the innercannula 30, including any protruding portions, is smaller than thewidest outer diameter (e.g., 15 mm) of the outer cannula connector 28.It should be understood that, the inserted portions of the compressibleend region 32 press against the interior wall 93 of the outer cannulaconnector 28 and feature an outer diameter that is slightly smaller(e.g., 12 mm or smaller) than the inner diameter of the outer cannulaconnector 28. Further, the inner cannula 30 may feature regions withdifferent outer diameters along its length in either configuration.

Because the inner cannula 30 is configured to be inserted and/or removedby an operator, the proximal end 34 may protrude from the outer cannulaconnector 28 to allow the compressible end region 32 to be manipulatedwhile the inner cannula 30 is in place. For example, the proximal end 34protrudes proximally or along a rotational axis 95 of the outer cannulaconnector 28. The axis 95 is generally orthogonal to the axis 98 along alongest dimension of the flange member 20. When inserted in the patient,the inner cannula 30 may be positioned so that the operator grips theproximal end and pushes laterally (e.g., along the axis 98).Accordingly, the openings 90 may be positioned to correspond with adorsal and ventral side of the tube 10 (e.g. to correspond with theinner curve 50 and the outer curve 52 of the inner cannula, see FIG. 3)when inserted to encourage lateral compression. In other embodiment, theopenings 90 may be positioned to encourage dorsal-ventral compression.

FIG. 5 is a perspective view of an inner cannula 30 in the uncompressedconfiguration. In the depicted configuration, the proximal end 34assumes its largest unbiased outer diameter 70. When force is appliedalong arrows 110, the first ear 112 and the second ear 114 move towardsone another (e.g., along axis 98, see FIG. 4) and the gaps 92 formed bythe openings 90 decrease as the compressible end region 32 assumes thesmaller, compressed outer diameter 84 (see FIG. 4). For example, anapplication of 5N of force or less may be applied to achieve sufficientcompression to insert the inner cannula 30. In other embodiments, thecompressible end region 32 may form a single gripping structure or morethan two ears.

FIG. 6 is a detail view of the compressible end region 32. In particularembodiments, the compressible end region 32 may include mating featuresthat couple to complementary features on the interior wall 93 of theouter cannula connector 28 (see FIG. 4). Such mating features mayprevent rotational movement of the inner cannula 30 relative to theouter cannula connector 28. In addition, the mating features may provideadditional alignment to facilitate correct alignment of the curve of theinner cannula 30 with the curve of the outer cannula 12 (see FIG. 3). Asdepicted, the mating features may be protrusions, such as protrusion 122formed on an exterior surface 120 of the inner cannula 30. Theprotrusion 122 may be formed in any suitable shape or combination ofshapes, such as a rounded bump, a ramp shape, a pyramid structure, etc.Further, the compressible end region 32 may include any number ofprotrusions 122 positioned about a circumference. For example, thecompressible end region 32 may include two protrusions 122 that opposeone another. In specific embodiments, opposing protrusions 122 may becircumferentially centered on the ears 112 and 114. In such embodiments,the protrusions 122 may serve as guides for an operator to press againstto bias the ears 112 and 114 towards one another. In another embodiment,the protrusions 122 may be about 90 degrees from opposing notches 90. Inanother embodiment, respective protrusions 122 may be provided as apartial ring with an arc having less than 45° of circumference of thecompressible end region 32. In another embodiment, the protrusion 122may form a ring about the circumference of the compressible end region32.

It should be understood that the mating features may also be implementedas recesses or a combination of protrusions and recesses. The size ofthe protrusion 122 may be selected to fit into a corresponding recess inthe outer cannula connector 28 and may be less than a thickness of thewall of the outer cannula connector 28. In one embodiment, theprotrusion 122 may protrude less than about 1 mm, less than about 1.5 mmor less than about 2 mm from the exterior surface 120. In particularembodiments, the protrusions 122 protrude less than a widest diameter 70in an uncompressed configuration. Alternatively, the protrusion 122 mayfit into complementary windows formed in the outer cannula connector. Insuch embodiments, the protrusion 122 may be larger. The inner cannula 30may also include additional support structures, such as one or more ribs124. In the depicted embodiment, the rib 124 may provide structuralsupport to the protrusion 122. In addition, the compressible end region32 may feature regions of varying outer diameters that form a slope 126.The slope 126 may be formed proximate to the protrusion 122 tofacilitate insertion of the relatively larger protrusion 122 into theouter cannula connector 28.

FIG. 7 is a top view of the inner cannula 30 showing the position of twoopposing protrusions 122 relative to the proximal end 34. The positionof the protrusions 122 may be measured from the midpoint 130 or thedistal-most point 132. In one embodiment, the distance 140 from theproximal end 34 of the inner cannula 30 to the distal-most point 132 ofthe protrusion 122 may be selected to place the protrusion 122 withinthe interior of the outer cannula connector 28 (see FIG. 4). In anotherembodiment, the protrusion 122 may be positioned relative to a distalterminus 142 of opposing openings 90. As depicted, the openings 90 aregenerally oriented along the rotational axis 95. However, it should beunderstood that the openings 90 may be irregularly shaped. Accordingly,the distal terminus may be the distal-moist point of the opening 90 fromthe proximal end 34.

In one embodiment, the protrusion 122 is located proximally relative tothe distal terminus 142. In other words, the distance 140 is less than adistance 144 (the distance from the proximal end 34 to the distalterminus 142). Further, the ratio of the distance 140 to the distance144 may be selected such that the protrusions 122 are generally closerto the distal terminus 142 than the proximal end 34. For example, theratio may be greater than 0.5 or greater than 0.75. Such animplementation may allow the protrusions 122 to be biased sufficientlytoward one another to ease insertion in the outer cannula connector 28.That is, if the proximal end region 32 is flared, positions closer tothe distal terminus 142 may be within smaller diameter regions. Incertain embodiments, the distal terminus 142 is also positioned withinthe outer cannula connector 28. Depending on the size and length of theouter cannula connector 28, in particular embodiments, the distance 144may be less than about 15 mm, less than about 12 mm, less than about 10mm, less than about 9 mm, less than about 8 mm, less than about 7 mm,less than about 6 mm, or less than about 5 mm.

The proximal end 34 may also terminate in a lip 150 that is formed inthe wall 94. The relatively thicker lip 150 may also extend at leastpartially towards the distal terminus 142 and terminate in an abutmentsurface 152. The abutment surface 152 is configured to abut the proximalend 44 of the inner cannula connector and prevent further movement ofthe inner cannula 30 distally, which may assist in aligning the innercannula 30 within the outer cannula 12. In certain embodiments, adistance 160 from the abutment surface 152 to the proximal end 34 isless than the distance 140 and the distance 144. In particularembodiments, the distance 160 is less than 50% of the distance 144 or isless than 50% of the distance 140. In a particular embodiment, thedistance 160 is about 4 mm. Further, in another embodiment, the distancebetween a midpoint 130 and the abutment surface 152 may be less than thedistance 160, e.g., may be about 3 mm.

As noted, the proximal end 34 of the inner cannula 30 is positionedoutside of the outer cannula connector 28, which facilitates operatormanipulation of the inner cannula 30. FIG. 8 is a partial perspectivecomponent view of the interaction between the outer cannula connector 28and the proximal end 34. The position of the abutment surface 152determines how much the proximal end 34 protrudes from the proximal end44 of the outer cannula connector 28. A more distal abutment surface 152results in greater protrusion. The length 170 of the protrusion may beabout 4 mm or less. In other embodiments, the length 170 of theprotrusion is selected to avoid interference with couplings formed bythe outer cannula connector 28. In addition, the inner cannula 30 mayinclude features that facilitate gripping by an operator. The thickness172 of the lip 150 may be selected to maintain the desired outerdiameter 84 and also form a gripping end. The lip 150 may be slightlythicker than the inserted portion of the compressible end region 32.

In certain embodiments of the present techniques, the inner cannula 30is retained in place by the compression force of the compressibleproximal end 32 against the interior surface 93 of the outer cannulaconnector 28. That is, the force against the outer cannula connector 28reflects the material and geometric properties of the compressible endregion 32 and a tendency of the compressible end region 32 to return toa default uncompressed configuration. In one embodiment, the compressionforce is sufficient to form a seal between the compressible end region32 and the outer cannula connector 28. In one embodiment, thecompressible end region 32 has one or more mating features that mayalign the inner cannula 30 within the outer cannula 12 and/or mayprevent rotational dislodgment.

FIG. 9 is a perspective view of an outer cannula connector 28 thatincludes complementary features to such mating features. The -outercannula connector 28 is typically coupled to the outer cannula 12 (seeFIG. 1) at its distal end 180. The outer cannula connector 28 may alsoinclude distal features 182 for coupling to the flange member 20 (seeFIG. 1), such as threading connectors, snap-in features, and/or one ormore windows or recesses to facilitate heat bonding. In certainembodiments, the outer cannula connector 28 may include one or morerecesses (e.g., recesses 184 and 186) that are sized and shaped toaccommodate complementary protrusions on a compressible end region 32 ofan inner cannula 30. It should be understood that the complementaryfeatures may be selected based on the characteristics of the matingfeatures. Accordingly, if the mating features are protrusions, thecomplementary features are recess or windows and vice versa. Similarly,the position of the complementary features may be selected to facilitateproper alignment and insertion of the inner cannula 30. FIG. 10 is across-section of the outer cannula connector 28 of FIG. 9, showing theposition of the recess 184.

It is envisioned that the tracheal tube assembly 10 as provided hereinmay be provided as an assembly and/or as a kit. A kit may include apackaging that encloses an inner cannula 30 sized for an outer cannula12, which may include an affixed outer cannula connector 28 and flangemember 20. The kit may also include a neck strap for retaining thetracheal tube 10 in place. The kit may also include an obturator 190,shown in FIG. 11. Other components of the kit may include a capconfigured to be placed on a proximal end 34 while the obturator 190 isin use and that may be part of the obturator 190. The tube assembly 10components (e.g., outer cannula 12, flange member 20, outer cannulaconnector 28, cuff 16, and pilot balloon assembly 18) may be assembledprior to in situ assembly of the inner cannula 30 into the outer cannula12. Indeed, the user or clinician may perform final assembly of thetracheal tube 10 by selecting a desired inner cannula 30 from aselection of inner cannulas and then inserting the inner cannula 30 intothe outer cannula 12 prior to intubation. Thus assembled, the trachealtube 10 may then be inserted into the patient's trachea.

Components of the tube assembly 10 may be manufactured according tosuitable techniques. For example, the inner cannula and/or outer cannula12, including the outer cannula connector 28, may be molded, overmolded,two shot molded, computer numerical control (CNC) machined, milled, orotherwise formed into the desired shape. In one embodiment, a mold ormold form may be used to manufacture the inner cannula 30. In oneembodiment, the mold or other manufacturing technique may facilitate aspeckled outer surface of the inner cannula 30, which may facilitateinsertion. One or more components may be manufactured of materials suchas a polyethylene (e.g., low density polyethylene), polypropylene, PTFE,expandable PTFE, polyvinyl chloride (PVC), a PEBAX silicone, apolyurethane, thermoplastic elastomers, a polycarbonate plastic, asilicon, or an acrylonitrile butadiene styrene (ABS). In particularembodiments, the material of the inner cannula 30 may be selected to be60 Shore D.

While the disclosure may be susceptible to various modifications andalternative forms, specific embodiments have been shown by way ofexample in the drawings and have been described in detail herein.However, it should be understood that the embodiments provided hereinare not intended to be limited to the particular forms disclosed.Indeed, the disclosed embodiments may not only be applied to airwaydevices, but these techniques may also be utilized for connectionsbetween inner and outer conduits for other types of medical devices andmedical connective tubing. Rather, the various embodiments may cover allmodifications, equivalents, and alternatives falling within the spiritand scope of the disclosure as defined by the following appended claims.

What is claimed is:
 1. A tracheal tube, comprising: a connectorcomprising an inner wall; a cannula configured to be inserted at leastpartially in the connector, wherein the cannula comprises a compressibleproximal region comprising: a first ear; and a second ear separated fromthe first ear by opposing notches formed in a wall of the compressibleproximal region, and wherein the first ear and the second ear areconfigured to be biased toward one another when the cannula thecompressible proximal region is coupled to the connector; and arotational lock comprising at least one of a first recess or a firstprotrusion, wherein the at least one of the first recess or the firstprotrusion is disposed on the inner wall of the connector, and at leastone of a second protrusion or a second recess, wherein the at least oneof the second protrusion or the second recess is disposed on an outersurface of the first ear, the second ear, or both, wherein therotational lock is configured to block rotation of the cannula when theat least one of the first recess or the first protrusion engages withthe at least one of the second protrusion or the second recess.
 2. Thetracheal tube of claim 1, wherein the at least one of the secondprotrusion or the second recess is positioned approximately 90 degreesfrom each notch of the opposing notches.
 3. The tracheal tube of claim1, wherein the cannula comprises a lip forming a proximal terminus ofthe cannula and configured to be outside of and proximal to theconnector when the cannula is inserted in the connector.
 4. The trachealtube of claim 1, wherein an outer diameter of the compressible proximalregion varies between a proximal end and a distal end of thecompressible proximal region.
 5. The tracheal tube of claim 1, whereinthe compressible proximal region of the cannula comprises a slopedregion formed proximate to the at least one of the second recess or thesecond protrusion.
 6. The tracheal tube of claim 1, wherein the at leastone of the second protrusion or the second recess forms a partial ringwith an arc having less than 45 degrees of a circumference of thecompressible proximal region.
 7. The tracheal tube of claim 1, whereinthe at least one of the second protrusion or the second recess forms aring about a circumference of the compressible proximal region.
 8. Thetracheal tube of claim 1, comprising an outer cannula coupled to andextending away from a distal end of the connector, wherein the cannulais disposed within the outer cannula when the cannula is inserted in theconnector such that a distal end of the cannula is adjacent to thedistal end of the outer cannula.
 9. A tracheal tube, comprising: anouter cannula configured to be positioned within a patient's airway; anouter cannula connector coupled to a proximal end of the outer cannulaand comprising at least one of a first recess or a first protrusiondisposed on an inner wall of the outer cannula connector; and an innercannula configured to be inserted at least partially in the outercannula connector such that a distal end of the inner cannula isadjacent to a distal end of the outer cannula wherein the inner cannula,comprises a compressible proximal region configured to be positionedwithin the outer cannula connector, wherein the compressible proximalregion has a compressed configuration comprising a first diameter whenpositioned within the outer cannula connector and an uncompressedconfiguration comprising a second diameter larger than the firstdiameter when the compressible proximal region is unbiased and outsideof the outer cannula connector, and wherein the compressible proximalregion comprises at least one of a second protrusion or a second recess,wherein the at least one of the second protrusion or the second recessis disposed on an outer surface of the compressible proximal region,wherein the at least one of the second protrusion or the second recessis complementary to the at least one of the first recess or the firstprotrusion and is configured to engage with the first recess or thefirst protrusion to block rotation of the inner cannula when thecompressible proximal region is disposed within and coupled to the outercannula connector.
 10. The tracheal tube of claim 9, wherein the atleast one of the second protrusion or the second recess is sized toengage with the at least one of the first recess or the firstprotrusion.
 11. The tracheal tube of claim 9, wherein the compressibleproximal region of the inner cannula comprises a sloped region formeddistal to the at least one of the second protrusion or the secondrecess.
 12. The tracheal tube of claim 9, wherein the at least one ofthe second protrusion or the second recess forms a partial ring with anarc having less than 45 degrees of a circumference of the compressibleproximal region.
 13. The tracheal tube of claim 9, wherein thecompressible proximal region comprises a first ear and a second earseparated from the first ear by opposing notches formed in a wall of thecompressible proximal region, wherein each notch of the opposing notchesis adjacent to both the first and second ears such that the first andsecond ears are joined at a distal terminus of each notch of theopposing respective notches, and wherein the first and second ears areconfigured to be biased toward one another to place the compressibleproximal region in the compressed configuration.
 14. An inner cannulaconfigured to be inserted at least partially in an outer cannulaconnector coupled to a proximal end of an outer cannula comprising: acompressible proximal region configured to be positioned within theouter cannula connector, wherein the compressible proximal region has acompressed configuration comprising a first diameter when positionedwithin the outer cannula connector and an uncompressed configurationcomprising a second diameter larger than the first diameter when thecompressible proximal region is unbiased and outside of the outercannula connector; a lip forming a proximal terminus of the innercannula and configured to be outside of and proximal to the outercannula connector when the inner cannula is inserted in the outercannula; and a rotational lock comprising at least one of a recess or aprotrusion disposed on an outer surface of the compressible proximalregion, wherein the at least one of the recess or the protrusion isconfigured to engage the outer cannula connector to block rotation ofthe inner cannula when the compressible proximal region is disposedwithin and coupled to the outer cannula connector.
 15. The inner cannulaof claim 14, wherein the at least one of the recess or the protrusionforms a partial ring with an arc having less than 45 degrees of acircumference of the compressible proximal region.
 16. The inner cannulaof claim 14, wherein the at least one of the recess or the protrusionforms a ring about a circumference of the compressible proximal region.17. The inner cannula of claim 14, wherein an outer diameter of thecompressible proximal decreases toward a distal end of the innercannula.